Compression device with S-shaped bladder

ABSTRACT

A device for applying compression treatment to a part of a wearer&#39;s body includes an S-shaped bladder with at least first and second spaced apart sections in fluid communication. At least one opening is formed between the first and second sections. The at least one opening may a single opening extending along a majority of a length of the first and second sections. The at least one opening may be a plural of openings. At least one opening may be formed between the second section and a third section of the bladder.

FIELD OF THE INVENTION

The present invention is directed generally to a compression device forapplying compression therapy to a body part of a wearer, moreparticularly a compression sleeve.

BACKGROUND OF THE INVENTION

A major concern for immobile patients and like persons are medicalconditions that form clots in the blood, such as, deep vein thrombosis(DVT) and peripheral edema. Such patients and persons include thoseundergoing surgery, anesthesia, extended periods of bed rest, etc. Theseblood clotting conditions generally occur in the deep veins of the lowerextremities and/or pelvis. These veins, such as the iliac, femoral,popiteal and tibial return deoxygenated blood to the heart. For example,when blood circulation in these veins is retarded due to illness, injuryor inactivity, there is a tendency for blood to accumulate or pool. Astatic pool of blood may lead to the formation of a blood clot. A majorrisk associated with this condition is interference with cardiovascularcirculation. Most seriously, a fragment of the blood clot can breakloose and migrate. A pulmonary emboli can form from the fragmentpotentially blocking a main pulmonary artery, which may be lifethreatening. The current invention can also be applied to the treatmentof lymphedema.

The conditions and resulting risks associated with patient immobilitymay be controlled or alleviated by applying intermittent pressure to apatient's limb, such as, for example, a leg to assist in bloodcirculation. For example, sequential compression devices have been used,such as the device disclosed in U.S. Pat. No. 4,091,864 to Hasty.Sequential compression devices are typically constructed of two sheetsof material secured together at the seams to define one or more fluidimpervious bladders, which are connected to a source of pressure forapplying sequential pressure around a patient's body parts for improvingblood return to the heart. The inflatable sections are covered with alaminate to improve durability and protect against puncture. As part ofthe compression device, the two sheets are structurally designed towithstand a changing pressure over time under repeated use.

The impermeability of the sleeve makes it uncomfortable for the patientbecause moisture (i.e. perspiration) is trapped between the impermeablesheet and the patient's body part. This leads to the patient'sunwillingness to wear the sleeve, thereby, endangering the health of thepatient. Moreover, the sleeve is generally non-stretchable and bulkybecause the bladders must be able to retain a significant amount offluid pressure during treatment. Thus, the prior art sleeves restrictthe mobility of the patient. Also chafing of a patient's limb can occurbecause the prior art designs retain the inflatable bladders in a fixedposition when under pressure. As the pressure changes during treatment,the bladders press and release against the patient's limb, rubbing andchafing the skin. A bladder may wrinkle or fold which can cause furtherirritation during a compression cycle. The final construction of a priorart sleeve is bulky, rigid and may feel heavy to a person over anextended period of use. The present invention is directed to solving theabove mentioned deficiencies without compromising durability andclinical effectiveness.

As stated above, prior art devices are constructed for durability andstrength. As shown in U.S. Patent Publication No. 2005/0187503 A1 toTordella, Tordella describes a sleeve with a top and bottom sheet. Thesheets are fixed at the perimeter to form an inflatable section orbladder, as shown in FIG. 2. The material forming the chambers orbladders is polyvinyl chloride or polyethylene. These materials areimpervious to moisture as they need to be fluid tight and thick enoughto withstand thousands of compression cycles without bursting. Tordellaprovides some cooling when the device provides for vent holes placedabout the sleeve. Also, a slit is introduced through the sheets, butTordella's slit is not within the area defined by the chambers (i.e.bladders). Generally, access to skin will provide evaporation of bodilyfluids collected at the openings, but the Tordella invention does notprovide for removing fluid trapped beneath the impervious sheet awayfrom the openings. The evaporation is limited to the openings and theimmediate area under the impervious sheet near the opening. At leastsome of the embodiments of the present invention provide a solution tothe problem of trapped fluid by moving the fluid from underneath theimpervious sheet, at a sufficient rate, to a plurality of openingspositioned, sized and shaped to maintain blood flow and evaporate themoisture as described below. The Tordella sleeve construction is similarto the Model 9529 SCD Express device (knee length sleeve) available inthe United States from Tyco Healthcare Group L.P., which is discussed inmore detail below.

There are other prior art attempts to improve comfort throughbreathability and evaporation. U.S. Pat. No. 3,824,492 to Nicholas isdirected to a garment that provides pulsating pressure to a lowerextremity. A number of holes are placed at the toe area. Air enteringthe holes is pulled across the patient's skin through an air spaceprovided by the device when worn. Nicholas has a hard outer shell. TheNicholas device suffers from a number of drawbacks not found in thepresent invention. The compression sleeves of at least some embodimentsof the present invention are elastic, at the inner layer and outerlayer, to improve patient mobility and flexure. Instead of a hard outershell like Nicholas, the present invention has in some embodiments abreathable, soft and elastic outer covering. The elastic outer cover ofthe present invention helps the sleeve conform to the limb underpressure. The present invention does not have the structure for achannel at the skin to move air across the skin and into the ambientenvironment.

Hasty (U.S. Pat. No. 4,091,804) and Annis (U.S. Pat. No. 4,207,876)disclose a plurality of openings in communication with a ventilationchannel. Air is forced through the channel and openings onto the skin bya compressor. The present invention does not use a ventilation channelwithin the layers of the sleeve. Furthermore in preferred embodiments ofthe present invention, the compression sleeve does not use itscompressor to force the air through the openings onto the skin thoughthe channel. In embodiments of the present invention, air at theopenings interfaces with the wicking material to evaporate wickedmoisture as described more fully below. The transport mechanism can bethe wicking material in present invention. Other devices such as Jacobs(U.S. Pat. No. 5,489,259), provide for direct access to a portion of thepatient's limb, but the Jacobs' device suffers in that cooling(evaporation) is limited to the localized openings. The Neal reference(U.S. Pat. No. 5,693,453), describes openings of various geometries, butthe size, shape and distribution is a matter of convenience of use. TheNeal device is not directed to prophylaxis treatment.

Breathability is associated with cooling through evaporation, as airmust be allowed to pass over the openings to the skin. Fasterevaporation can occur if a device can breathe through its outer layerwhich is a problem not solved in the cited references. A number of citedreferences mention breathing to avoid sweat build-up, but none of thereferences are directed to providing prophylaxis treatment usingsequential compression. A device to Hall (U.S. Pat. No. 6,520,926),describes a support socking that is breathable, but Hall provides noadditional detail on how it is made breathable. A device to Roth (U.S.Pat. No. 7,044,924), describes that various sized holes may be punchedthrough both the inner and outer sheet 202/204, between adjacent seams234 or 242 to allow for ventilation. Further, a moisture-wicking liningmaterial may be applied to the surface of the inner sheet 204 forcomfort. The lateral seams 230, 232 and 234 and the longitudinal seams238 and 240 form a plurality of inflatable bladders 250. The Applicantsadapt their inner sheet to provide wicking properties because theApplicants discovered laminating or applying the wicking material to asheet may compromise the wicking ability of material. The fibers of thewicking material would be interrupted, made discontinuous by thelamination; therefore, interfering with the capillary action of thewicking fibers as described below.

Roth may introduce a low pressure area adjacent to bladders which hasbeen shown to promote blood pooling. The Applicants particularlystructured at least some embodiment of their device to avoid bloodpooling by configuring adjacent bladders to minimize low pressure areasbetween the adjacent bladders. Applicant's device was demonstrated tomaintain clinical efficacy as described below. Roth does not provide anyinformation regarding the clinical efficacy of its device and does notprovide any figures showing its openings or its wicking material. A sockdevice to Linnane (U.S. Patent Publication No. 2006/0010574), describesa compression stocking with a wicking material near the person's skinfor wicking moisture along channels to the outside of the stocking. Thepresent invention directs moisture to a plurality of openings sized,shaped, and located along the compression device for maximizingevaporation while maintaining clinical efficacy.

Elasticity is found in the prior art and is commonly understood to be animportant benefit for compression stockings such as the T.E.D®, sold bythe assignee of the present invention. A drawback of the prior artsequential compression devices, like that shown in Hasty, is that thebladder material is flexible but not elastic. The prior art bladders areformed as part of a laminated construction adding further rigidity anddurability. The Tordella reference discloses a sleeve with flexible,elastic sections between the inflatable sections or portions tofacilitate mobility of a patient. Tordella does not disclose an elasticdesign circumferentially and longitudinally along the sleeves entirelength, which is solved by the present invention.

The present invention helps overcome patient discomfort withoutdecreasing clinical effectiveness, as shown in supporting lab testsdisclosed in this application. An important objective is to improvepatient compliance, defined as using the sleeve as prescribed by adoctor. There is a direct correlation of patient compliance with patientcomfort. Compliance with mechanical compression devices has always beena concern in healthcare. A clinical staff is overworked with patientloads and duties and thus one-on-one patient care time is at a premium.Often it has been reported that patients will become uncomfortablewearing compression sleeves and request that the sleeves be taken off,even though they may be necessary to prevent a fatal occurrence of apulmonary embolism. Clinical staff may not have time to fully educatethe patient on the importance of wearing the sleeve, and may not havethe time to ensure that the patient is constantly wearing the sleeve.For example, a research study performed by the CMAJ Clinical PracticeGuidelines for the Care and Treatment of Breast Cancer, discussedtreating lymphedema associated with breast cancer. The study indicatespatients are not compliant because the devices are generally difficultto use and not comfortable. It is this reason that compression sleevemanufacturers are trying to introduce more comfortable sleeves whilemaintaining the clinical efficacy already found in the prior artdevices. With the need for shorter stays at the hospital and moreoutpatient surgery, the need for more a comfortable device that iseasier to use, while maintaining clinical efficacy, is a long-felt needin the industry.

As stated above there is a long felt need, not found in prior artsleeves for improving comfort without compromising clinicaleffectiveness. Other prior art devices on the market, such as Aircast®,Huntleigh®, and Hill-Rom® suffer from a number of drawbacks, disclosedbelow, and solved in the present invention. Preferred embodiments of thepresent invention provide substantial cooling without compromising theclinical efficacy of the prior art devices such as Kendall's Model 9529and 9530 compression sleeves in providing prophylaxis DVT. The presentinvention is directed to improving patient comfort and thus compliancein terms of physician prescribed use. The following list of features isincluded in the construction of at least some embodiments of the presentinvention: soft, cool, easy to use and apply, non-irritating, flexible,fit a patients changing needs, and improved patient compliance.

The present invention in its preferred embodiments is engineered toprovide the maximum amount of evaporation, which is a function ofwicking properties and opening size, location and shape, whileminimizing any negative impact on blood flow augmentation or clinicalefficacy. Blood flow is dependent on opening size, shape and location,that is, the opening properties must be minimized not to interfere withblood flow, while maximizing the evaporation of trapped moisture beneaththe impervious layer.

As is known in the art, a compression sleeve is used to provideprophylaxis treatment to a wearer's body part. This treatment is to helpprevent the formation of blood clots by increasing the velocity ofblood, in a cascading manner along a limb toward the heart. Theillustrated and described embodiments of the present invention wraparound the full circumference around a patient's limb. The embodimentsof the present invention are not limited to full wrap devices. Thestructural changes that accomplish the features described below willenhance the comfort and use of the prior art devices, but notnecessarily at the expense of their claimed clinical efficacy.

SUMMARY OF THE INVENTION

In one aspect of the present invention, a device for applyingcompression treatment to a part of a wearer's body generally comprisesat least one inflatable bladder. The bladder has a generally S shapewith at least first and second spaced apart sections in fluidcommunication. At least one opening is formed between the first andsecond sections.

Other features will be in part apparent and in part pointed outhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front elevation of one embodiment of a compression sleevewith an outer cover and intermediate layers of the sleeve partiallyremoved to show underlying layers;

FIG. 2 is an exploded perspective of the compression sleeve;

FIG. 3 is a rear elevation of an inner layer of the compression sleeve;

FIG. 4 is a front elevation of the compression sleeve with the outercover removed;

FIG. 5 is a longitudinal section of the compression sleeve withinflatable bladders of the sleeve in an inflated state;

FIG. 6 is a longitudinal section of the compression sleeve with theinflatable bladder in a deflated state;

FIG. 7 is an enlarged fragmentary elevation of the outer coverillustrating loop material;

FIG. 8 is an exploded perspective of another embodiment of a compressionsleeve;

FIG. 9 is a front elevation of the compression sleeve of FIG. 8 with anouter cover removed;

FIG. 10 is an exploded perspective of another embodiment of acompression sleeve;

FIG. 11 is a front elevation of the compression sleeve of FIG. 10 withan outer cover removed;

FIG. 12 is a front elevation of another embodiment of a compressionsleeve, similar to the embodiment of FIG. 11, with an outer coverremoved;

FIG. 13 is a front elevation of another embodiment of a compressionsleeve;

FIG. 14 is a front elevation of another embodiment of a compressionsleeve with an outer cover partially removed to show intermediate layersand an inner layer;

FIG. 15 is a front elevation of yet another embodiment of a compressionsleeve with an outer cover partially removed to show intermediate layersand an inner layer;

FIG. 16 is a section of another embodiment of a compression sleeve,similar to FIG. 5 with components of the sleeve being secured togetheralong a single peripheral seam line;

FIG. 17 is an enlarged detail of the seam line illustrated in FIG. 16.

FIG. 18 is a front elevation of another embodiment of a compressionsleeve with an outer cover partially removed to show underlying layers;

FIG. 19 is a rear elevation of the embodiment of FIG. 18;

FIG. 20 is a front elevation of a compression sleeve of anotherembodiment with an outer cover and intermediate layers of the sleevepartially removed to show underlying layers;

FIG. 21 is a graph of a percent of liquid evaporated over time forvarious compression sleeves including the sleeve of the presentinvention; and

FIG. 22 is a percent of blood flow augmentation at 6% open area persleeve for various opening shapes.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, and in particular to FIGS. 1 and 2, oneembodiment of a compression device (broadly, “a garment or a sleeve”) isgenerally indicated at 10 for applying sequential compression therapy toa limb of a wearer. The compression sleeve is of the type sized andshaped for being disposed around a leg of the wearer, but could beconfigured for application to other parts of the wearer's body. Morespecifically, the sleeve 10 has a width W (FIG. 1) for being wrappedaround a full circumference of the leg and a length L (FIG. 1) forrunning from the ankle to a thigh of the leg. This type of sleeve isgenerally referred to in the art as a thigh-length sleeve. It will beunderstood that a compression sleeve may come in different sizes, suchas a knee length sleeve (FIG. 20) that extends from the ankle up thecalf of the leg. It is understood that other types of compressiondevices for being disposed about other limbs of the wearer's body, arewithin the scope of this invention, such as a wrap around a patient'schest in the treatment of breast cancer.

A numerical study performed by R. D. Kamm, titled “BioengineeringStudies of periodic External Compression as Prophylaxis Against DeepVein Thrombosis—Part I: Numerical Studies” concluded, among otherthings, that “the entire length of the veins should be emptied as fulland as rapidly as possible.” The Kamm study reviews three types ofcompression, the one of interest is wavelike compression. Wavelikecompression is most similar to sequential compression provided by theillustrated embodiments of the present invention. The Kamm Study foundwavelike compression is most effective in moving blood for an effectiveprophylaxis treatment.

Referring to FIG. 1, the compression sleeve 10 comprises four layerssecured together in the illustrated embodiment of the present invention.The scope of the present invention is not limited to four layers. Morespecifically, the compression sleeve comprises an inner layer, generallyindicated at 12, on which a first intermediate layer (broadly, a firstbladder layer), generally indicated at 14, is overlaid. A secondintermediate layer (broadly, a second bladder layer), generallyindicated at 16, overlies the first intermediate layer 14 and is securedthereto. An outer cover generally indicated at 18, overlies and issecured to the second intermediate layer 16. In use, the inner layer 12is disposed most adjacent to the limb of the wearer and is in contactwith the limb of the wearer, and the outer cover 18 is most distant fromthe limb of the wearer. A knee opening 19 is formed through the sleeve10 that is generally aligned with the back of the knee when the sleeveis applied to the leg. The layers have the same geometric shape and aresuperposed on each other so that edges of the layers generally coincide.It is contemplated that one or more of the layers 12, 14, 16, or 18 maynot be superposed on a corresponding layer, but slightly offset toaccommodate a particular feature of a patient's limb. Moreover, thenumber of sheets or thickness making up each layer 12, 14, 16, or 18 ofthe compression sleeve 10 may be other than described. The thickness ofthe layers may vary to add strength or to cause more expansion in onedirection, such toward the limb, during inflation.

Referring to FIGS. 1, 2 and 4, the first and second intermediate layers14, 16, respectively, each include a single sheet of elastic material(broadly, “bladder material”). For example, the sheets 14 and 16 aremade of a pliable PVC material as the bladder material. Layers 12 and 18are made of a polyester material. The second intermediate layer 16 issecured to the first intermediate layer 14 via three separate bladderseam lines 22 a, 22 b, 22 c defining a proximal bladder 24 a, anintermediate bladder 24 b and a distal bladder 24 c, respectively, thatare spaced apart longitudinally along the sleeve 10. The number ofbladders may be other than three without departing from the scope of thepresent invention. As used herein, the terms “proximal”, “distal”, and“intermediate” represent relative locations of components, parts and thelike of the compression sleeve when the sleeve is secured to thewearer's limb. As such, a “proximal” component or the like is disposedmost adjacent to a point of attachment of the wearer's limb to thewearer's torso, a “distal” component is disposed most distant from thepoint of attachment, and an “intermediate” component is disposedgenerally anywhere between the proximal and distal components.

For reasons discussed below, the proximal bladder 24 a defines aproximal, lateral extension 25 near the upper edge margin of the sleeve10. The bladders 24 a, 24 b, 24 c are circumferential bladders meaningthat they are sized and shaped to be wrapped around substantially theentire circumference of the wearer's limb or very nearly the entirecircumference of the limb. For example, in one embodiment the bladders24 a, 24 b, 24 c each extend around at least 90% of a mediancircumference of a leg. However, prior art devices have partial bladderssuch as AirCast® and HillRom®, and these prior art devices do notprovide for openings, elasticity and other features of the presentinvention. It is to be understood that the construction described hereincan be adopted by the prior art sleeves with a partial bladderconstruction, without departing from the scope of the present invention.

The intermediate layers 14, 16 may be secured together by radiofrequencywelding, adhesive, or other chemical and/or mechanical process. It isunderstood that the intermediate layers 14, 16 may be secured togetherat other locations, such as around their peripheries and at bladder seamlines 22 a, 22 b, 22 c to further define the shape of the inflatablebladders 24 a, 24 b, 24 c. For purposes discussed below, the firstintermediate layer 14 is secured to the inner layer 12 along a seam line25 (FIGS. 5 and 6) that runs along the outer periphery of the firstintermediate layer 14 so that central regions of the bladders 24 a, 24b, 24 c are not secured to the inner layer 12. This permits the bladders24 a, 24 b, 24 c to move relative to the inner layer 12. The secondintermediate layer 16 may also be secured to the inner layer 12 alongthe same seam line 25. The first intermediate layer 14 may be secured tothe inner layer 12 by RF welding or adhesive or in other suitable ways.This structure improves comfort as described below.

Referring to FIGS. 2 and 4, each inflatable bladder 24 a, 24 b, 24 creceives fluid from a source of compressed fluid (not shown) via adedicated proximal bladder tube 26 a, intermediate bladder tube 26 b,and distal bladder tube 26 c, respectively, (FIG. 2). A tube line neednot be dedicated to a bladder to practice the invention. Each tube 26 a,26 b, 26 c is disposed between the intermediate layers 14, 16 andsecured to the respective bladder 24 a, 24 b, 24 c by the respectivebladder seam line 22 a, 22 b, 22 c. As shown best in FIGS. 2 and 4, thefirst intermediate layer 16 defines a cutout 27 (FIG. 2) so thatportions of the tubes 26 a, 26 b, 26 c are not disposed between theintermediate layers. Other ways of securing the tubes 26 a, 26 b, and 26c to the bladders 24 a, 24 b, and 24 c are within the scope of theinvention. The opposite ends of the tubes 26 a, 26 b, 26 c are groupedtogether using a second connector 30 (FIGS. 1 and 2) that is adapted tofluidly connect the tubes to the source of compressed fluid. The sourceof compressed fluid may be an air compressor under the control of amicroprocessor that sequentially pressurizes the bladders as isgenerally known in the art. An exemplary air compressor is described inU.S. Pat. No. 5,876,359 to Bock, the disclosure of which is incorporatedherein by reference. The bladders 24 a, 24 b, 24 c may be configured tocontain air pressurized to at least about 10 mm Hg (1333 Pa) to about 45mm Hg (6000 Pa). The bladders should be capable of being repeatedlypressurized without failure. Materials suitable for the sheets include,but are not limited to, flexible PVC material that will not stretchsubstantially. In another embodiment, the intermediate layers may form achamber for receiving an inflatable bladder that is formed separate fromthe chamber. In this embodiment, the layers may not be capable ofcontaining pressurized air as along as the inflatable bladders are socapable. It will be noted that the bladders 24 a, 24 b, 24 c can haveopenings 32 extending completely through the bladders, as described inthe embodiments of the present invention.

Referring particularly to FIGS. 1 and 4, the sleeve 10 defines aconnecting section including a pair of bridge members 84 on oppositesides of the knee opening 19 that extend between and connect a proximalportion of the sleeve that includes the proximal bladder 24 a to theremainder of the sleeve. The proximal tube 26 a generally lies along anaxis of bridge member 84 to provide structural, lengthwise support tothe sleeve 10. As shown best in FIG. 4, the cutout 27 in theintermediate sheet 16 does not extend through the bridge member 84. Theproximal tube 26 a extends between spaced apart distal spot welds 86disposed adjacent to a distal end of the bridge member 84 and betweenspaced apart proximal spot welds 88 disposed adjacent to a proximal endof the bridge member. The spot welds secure the tube 26 a to the bridgemember 84 such that the proximal bladder tube 26 a constitutes a rigidstructural component (broadly, a “first rigid structural component”) formaintaining the spacing between the proximal bladder 24 a and theintermediate bladder 24 b and in maintaining the longitudinallystructural integrity of the connecting section. In other words, thesleeve 10 is rigidified against collapsing or sliding down the wearer'sleg. As explained above, the proximal bladder tube 26 a is secured tothe proximal bladder 24 a at the proximal, lateral extension 25. Theproximal bladder tube 26 a runs along a side of a distal portion of theproximal bladder 24 a so that it does not enter the bladder until itreaches the proximal, lateral extension 25. Being secured at theproximal, lateral extension 25 of the bladder 24 a provides additionallongitudinal support to the sleeve 10 because the proximal bladder tube26 a extends lengthwise across more of the proximal portion of thesleeve than if the tube was secured at a distal portion of the bladder.In one embodiment, the proximal bladder tube 26 a extends at least aquarter of the way across a thigh section of the sleeve 10. In anotherembodiment shown in FIG. 4, the tube 26 a extends more than half wayacross the thigh section. This helps to keep the proximal portion of thesleeve 10 from collapsing and/or sliding out of position down thewearer's leg.

Referring to FIGS. 2 and 4, in addition to the proximal bladder tube 26a, a second rigid structural component 90, disposed between theintermediate layers 14, 16 and extending within the other bridge member84 of the connecting section, also provides longitudinal structuralsupport to the sleeve 10. The second structural component 90 extendsbetween proximal and distal ends of the bridge member 84. The respectiveproximal and distal ends of the structural component 90 are wider thanan intermediate portion of the component and the periphery of thecomponent generally conforms to the peripheries of side walls of thebridge member 84 so that the structural component is secured to thebridge member.

Referring to FIGS. 1, 3 and 4, the proximal bladder 24 a is secured tothe inner layer 12 and the outer cover 18 at spot welds 92 adjacent tothe bladder openings 32 and within an outer perimeter of the bladderdefined by the bladder seamline 22 a. The spot welds 92 maintain theouter cover 18 and the inner layer 12 in proper position with respect tothe bladders 24 a, 24 b, 24 c. In other words, the spot welds 92 preventthe bladders 24 a, 24 b, 24 c from substantially shifting relative tothe inner layer 12 and the outer cover 18 while still providing thesleeve 10 with substantial flexibility. Too much movement of inner layer12 and the outer cover 18 with respect to the bladders 24 a, 24 b, 24 cmay reduce the fit of the sleeve, thereby leading to reduced efficacy ofthe compression therapy. The proximal bladder 24 a is free fromsecurement to the inner layer 12 and outer cover 18 other than at thespot welds 92 to maintain flexibility of the sleeve so that mobility ofthe patient's leg is not compromised. Inner layer 12 may be joined tolayer 16 at the spot welds 86, 88, 92 or the inner layer 12 may bejoined at the seam line 34 of the opening 32. Away from the openings 32and spot welds 86, 88, 92, the inner layer 12 is not joined to surfaceof the bladder material forming the bladder that expands to providecompression treatment to the patient's limb.

In one embodiment, the bladders 24 a, 24 b, 24 c are constructed toexpand more toward the wearer than away from the wearer, therebyapplying a greater compressive force on the wearer's limb. In oneexample, the first intermediate layer 14 (i.e., the layer most adjacentto the inner layer 12) has a lesser thickness than that of the secondintermediate layer 16. With both layers 14, 16 being of the samematerial (i.e., elastic PVC material) the first intermediate sheet willhave a lower modulus of elasticity. Thus, when air is introduced intothe bladders 24 a, 24 b, 24 c, the bladders will expand more toward theinner layer 12 and the wearer than away from the wearer. It isunderstood that other ways, besides a difference in thickness betweenthe intermediate layers 14, 16, of constructing the bladders 24 a, 24 b,24 c so that they expand more toward the wearer than away from thewearer is within the scope of the invention.

Referring to FIGS. 2 and 3, the inner layer 12 is constructed of amaterial that is capable of wicking moisture near a patient's limb. Theinner (or “wicking”) layer 12, through capillary action, absorbsmoisture trapped near the leg or limb of the wearer, carries themoisture away from the surface of the limb, and transports the moisturefrom locations on the limb at the inner layer 12 where the moisture isabundant to areas where it is less abundant, at the openings 32, forevaporation to the ambient environment. The openings may be of varioussizes, shapes and locations within the bladder area providing thecompression. An opening 32 exposes the wicking layer to the ambient orsurrounding air as opposed to the portion of the wicking layer beneaththe bladder material. The portions of the inner layer 12 in registrationwith the openings 32 may be referred to as “exposed portions”. Otherways of exposing the wicking material are within the scope of thisinvention, such as slits or extending the wicking material outside theperimeter of the bladder material. The present invention has its exposedportion within the bladder area that provides compression. Thecompression region is the bladder area expanding and contracting underthe influence of air pressure or other fluids. The area of the bladdernot providing compression is the seamline or weld points which arepoints of the bladder material sealed together to provide an air orwater tight boundary or other regions of the opposed sheets 14, 16outside the perimeter of the bladder. The wicking material 12 may beinter-weaved with the impervious material to form the inner layer 12.The wicking material 12 transports moisture to an area of less moisture.The openings 32 must be engineered to maintain blood velocity, whilemaximizing evaporation of moisture. Suitable wicking materials may becomprised of, for example, some form of, polyester, although they may becomprised of polypropylene. Microfibers may be used. Suitable microfibermaterials include, but are not limited to, CoolDry model number CD9604,sold by Quanzhou Fulian Warp Knitting Industrial Co., Ltd., QuanzhouCity, Fujian Province, China and CoolMax®, sold by E. I. du Pont deNemours and Company, Wilmington, Del.

A number of lab tests were performed to determine the embodiments of thepresent invention. The tests looked at the evaporation rate, wickingperformance and elasticity to provide improved comfort withoutcompromising blood flow velocity. The study used Kendall's 9529 kneelength sleeve model and three other competitor models denoted as kneelength sleeves A, B and C. Third party testing has demonstrated thesuperior performance of a full length, circumferential wrap such asKendall's 9530. The American Journal of Surgery study “Effectiveness ofLeg Compression in Preventing Venous Stasis”, concluded a sequentialcompression device, like Kendall's 9530 model, is best at moving blood.The study concluded that DVT prophylaxis using the 9530 leg sleevedevice encounters fewer issues and problems than administering a drugsuch as Heparin, and the leg sleeve device was proven, to move contrastmedia injected in the blood along the patient's leg more effectivelythan the other methods described in the article.

As discussed above, the structural changes were directed to a sleevethat is softer; cools itself without compromising blood flow; is easy touse and apply; effectively eliminates irritation and pressure points; isflexible and elastic to improve patient mobility and is overallcompliant with the existing expectations for clinical efficacy. Toimprove softness the wicking material, at the inner layer 12, was chosento be a knitted sheet rather than an impervious non-woven such aspolyvinyl chloride.

Cooling is achieved in at least one embodiment by a combination ofwicking material and the openings 32. The openings allow for evaporationof the wicked moisture from a patient's limb. The wicking material 12 orinner layer was tested for the amount of fluid it could absorb from thepatient's skin based on the assumption that the area between the skinand the inner layer 12 would be laden with sweat. This is called thewicking rate in terms of moisture absorbed. Once the wicking materialabsorbed moisture, the next wicking test is how far the material couldmove the absorbed moisture. This is called the wicking rate in terms ofdistance. The wicking rate in terms of distance is important because itimpacts the location and number of openings 32, 34 in a bladder.Increasing the size and number of openings 32 impacts blood flow, asshown in FIG. 22, when the bladder pushes against the patient's limb tomove blood to the heart. Findings at FIG. 22 suggest larger openingsprovide the highest blood flow, but a larger opening may cause bloodpooling. The importance of the opening characteristics is describedbelow.

The next test was the amount of open bladder space as a percentage ofthe sleeve area for maximum evaporation and still be considered acompliant device. This is called the % Opening to Patients Skin. The %Open to Patients Skin (through the bladder) was maximized to improveevaporation, while maintaining a clinical efficacy of blood flow—asfound in the Model 9529 sleeves currently sold by Kendall. It is beneaththe bladder where the moisture and heat are trapped, which provides thediscomfort to the patient.

To summarize the evaporation improvement of a certain embodiment of thepresent invention, Table I is presented.

TABLE I Comparison of Sleeve Evaporation Cir- % cumferential OpeningWrap of the to Patients % % Bladder Skin Evaporation Evaporation aroundthrough of moisture of moisture Sleeve Type the Limb bladder at 1 hourat 8 hours 9529 Knee Yes 0% ~5% 12-18% Sleeve of Knee Yes ~6%  15%80-85% the Present Invention Sleeve A Knee No 0% 35% 90-95% Sleeve BKnee Yes 0% ~5% 35-40% Sleeve C Knee No 0% 25% 80-85%

The sleeves tested were the Kendall model 9529, a sleeve constructedaccording to the principles of the present invention as an improvementto the 9529 or 9530 models, a Hill Rom® ActiveCare knee length sleeve, aHuntleigh® Flowtron sleeve and an AirCast® VenaFlow calf cuff. Thecompetitor sleeves are represented as Sleeve A, B or C in the table.Table I demonstrates the unexpected results of the tested embodiment ofthe present invention. The tested embodiment of the present inventionimproves evaporation at least three times over the 9529 model within thefirst hour. At eight hours, the evaporation is about six times more thanthe 9529 model. The compression sleeve constructed according to theprinciples of the present invention gave final results comparable toSleeves A and C, which do not have bladders that extendcircumferentially around a limb or leg. The rate of evaporation is about10% liquid evaporated per hour for the sleeve of an embodiment of thepresent invention as compared to the 9529 model at 1.35% rate. The %Liquid Evaporated over time is presented in FIG. 21.

The testing used new sleeves. All sleeves are knee length. For thetested embodiment of the present invention, the knee length sleeve isshown in FIG. 20. The moisture loss due to evaporation is dependent onthe wicking properties of the inner layer 12, and the location, and sizeof the openings as well as their distribution pattern along and aroundthe sleeve as shown in the inverted waterdrop configuration of FIG. 1.

The wicking test was devised to characterize the absorption and movementof wicked fluid at the inner layer of the SCD Express device sold by theAssignee of the present application. First the Applicant will describethe wicking test procedure. The results of the wicking test have beentabulated and are discussed hereinafter. The wicking material is thevehicle to absorb and move the otherwise trapped fluid beneath theimpermeable bladder layer to the openings or external to the inside ofthe sleeve.

The optimal wicking rate and distance is dependent on the opening sizeand location which impacts blood flow or treatment. Kamm, describedpreviously herein, reached the conclusion that the entire length of theveins should be emptied and filled as rapidly as possible. This does notmean a partial bladder can not meet the Kamm result, but too manyopenings in a full circumferential body wrap can introduce bloodpooling. Thus, the key is to prevent blood pooling, which means thedevice is moving blood toward the heart, while maximizing cooling bymaximizing the size and number of openings throughout the body wrap. Thepattern of the openings 32 can help to maximize the number of openingsby arranging the waterdrops as shown in FIG. 1 and FIG. 4.

Next, the Applicant evaluated and determined the size, type, locationand number of openings for evaporating the wicked fluid. The openingsize and location impacts comfort and blood flow. Too many openings mayinterfere with placing the sleeve on the limb because the sleeve is tooloose and will not conform to the body part. Too many openings canreduce overall blood velocity. The pressure applied is directly relatedto blood velocity, that is, less pressure corresponds to lower flowrates of blood and uneven pressure may cause blood to pool at theopenings. The sleeve pressure may act as a tourniquet if not properlyplaced on the user. Too many openings can cause adjacent bladder areasto fold on one another creating a possible tourniquet effect whensecured using the hook and loop straps or flaps. If the openings are toolarge, this will lead to low pressure areas which can possibly lead tothe pooling of blood.

The wicking test is used to experimentally quantify the wickingcapability (i.e. absorption and movement) needed at the inner layer 12of the compression sleeve 10. First, a sample is cut from the innerlayer of the tested embodiment of the present invention and the priorart 9529 sleeve. The sample has a length of 6 in (15.24 cm) and a widthof 0.75 in (1.91 cm). Other lengths may be used. The sample is markedwith a longitudinal centerline so that the length of the strip isdivided into two 3 in (7.62 cm) portions. The sample is weighed, and itsweight is recorded as a starting weight. The sample is attached to a labstand or other structure. The lab stand has an arm extendinghorizontally from a vertical post. The vertical position of the arm onthe post is adjustable. The sample is attached adjacent to the free endof the arm so that the length of the sample extends downward,substantially perpendicular to the arm.

A 400 ml beaker of wicking fluid is placed underneath the sample as ithangs from the lab stand. The wicking fluid is room temperature tapwater with red food coloring added for contrast against the sample. Withthe beaker underneath the sample, the lab stand arm is lowered so thatthe sample is submerged into the wicking fluid to the centerline of thesample. The sample remains submerged for 60 seconds. After 60 seconds,the lab stand arm is raised to completely withdraw the sample from thewicking fluid. The sample remains above the beaker for 10 seconds toallow any excess absorbed fluid to drip off. After 10 seconds, thesample is cut in half at its centerline and the lower half of the sample(i.e., the portion of the sample that was submerged in the wickingfluid) is discarded. The other half of the sample (i.e., the topportion) is weighed on a digital scale with a precision of 1/100th gram.This weight is recorded, and the weight of the fluid that was wicked iscalculated by subtracting the original half-weight of the sample fromthe weight of the top portion after wicking. The sample is laid on aplastic sheet, and the distance the wicking fluid progressed is measuredfrom the cut end (i.e., the centerline) to the highest point to whichthe wicking fluid progressed. This distance is recorded.

After recording the progression of the wicking fluid, the sample remainsuntouched on the plastic sheet for 60 minutes at ambient roomtemperature conditions. After 60 minutes, the distance from the cut endof the top portion to the highest point to which the wicking fluidprogresses is measured. This distance is recorded. Next, the top portionis weighed on the digital scale, and its weight is recorded.

Using the recorded data above, the average wicking rate is determined interms of wicking distance for the material used at the inner layer,according to the following equation:WD _(60s)/60 s=distance/s,

where WD_(60s) is the average wicking distance of the four samples after60 seconds.

Moreover, the average wicking rate in terms of amount of fluid wicked atthe inner layer is calculated according to the following equation:WW _(60s)/60 s=amount wicked (g)/s,

where WW_(60s) is the average weight of the fluid wicked by the foursamples after 60 seconds.

Using the above testing approach, the wicking capabilities of CoolDrymodel number CD9604 were determined. Four samples are cut from a sheetof the CoolDry model number CD9604, and the samples were weighed. Asample each has a dry weight of 0.40 grams, so that the half-weight, andtherefore, the original weight of the top portion, is 0.20 grams. Themean weight of the top portion of the samples after 60 seconds in thewicking fluid totaled 0.49 grams, with the largest observed weight at0.50 grams and the smallest weight at 0.48 grams. The mean weight of thefluid wicked is 0.29 grams for a sample. The mean wicking distance forthe top portion of the samples after 60 seconds in the wicking fluid is2.25 in (5.72 cm), with the largest distance recorded at 2.31 in (5.88cm) and the smallest distance recorded at 2.19 in (5.56 cm). The meanweight of the top portion after 60 minutes at ambient room conditions is0.213 grams, with the largest weight recorded at 0.22 grams and thesmallest weight recorded at 0.21 grams. The mean wicking distance forthe top portion after 60 minutes at ambient room conditions is 2.82 in(7.16 cm), with the largest distance recorded at 3.00 in (7.62 cm) andthe smallest distance recorded at 2.63 in (6.68 cm).

Using the above data and equations, the average wicking rate in terms ofdistance (WD_(60s)) is about 0.0375 in/s (0.09525 cm/s). The averagewicking rate in terms of amount of fluid wicked (WW_(60s)) is about0.0048 g/s. The determined wicking rate and distance allows one toengineer the openings 32 about the sleeve for improving comfort whilemaintaining clinically acceptable blood flow. The mere inclusion ofwicking material does not ensure the cooling affect to the patient. Thewicking rate and distance must be correlated with the openingcharacteristics to ensure clinically effective blood flow augmentation,as tabulated in FIG. 22.

Preferably, the inner layer 12 has an average wicking rate in terms ofdistance (WD_(60s)) that is at least about 0.01 in/s (0.0254 cm/s) andan average wicking rate in terms of weight of fluid wicked (WW_(60s)) ofat least about 0.002 g/s.

The construction of wicking layer, openings, bladder and outer layer isdiscussed. The openings must be sized and shaped to maintain the bloodflow efficacy of a compression sleeve like model 9529 and to provideimproved evaporation of moisture for increasing patient compliance.Referring to FIGS. 1 and 4, the sleeve 10 is constructed so thatportions of the intermediate layers 14, 16 do not overlie the innerlayer 12 so that moisture wicked by the inner layer 12 travels to openportions of the inner layer 12 and evaporates to the atmosphere. In thisillustrated embodiment, each inflatable bladder 24 a, 24 b, 24 cincludes openings 32 that extend through the first and secondintermediate layers 14, 16, respectively, to the inner layer 12. One wayto form such an opening is to seal the intermediate layers 14, 16together within the periphery of the respective bladder 24 a, 24 b, 24 cusing a continuous sealing line 34. The portions of the intermediatelayers 14, 16 within a periphery of the sealing line 34 can be removed,such as by cutting, thereby forming the openings 32. Other ways offorming the openings 32 are within the scope of this invention. Once anopening size and pattern is determined, a metal die is cast to cut theopenings in the PVC bladder material for the opposing sheets.

For the preferred embodiment, the opening shape is generally shaped likea waterdrop. Each opening 32 is tapered from a first round end portiontoward a second,smaller round end portion. The openings 32 may be ofother shapes, such as circles, ovals, and slits, without departing fromthe scope of the invention. The opening shapes may be inter-mixed at thebladder without departing from the scope of the invention. Thewaterdrop-shape provided the clinically efficacy, as found in FIG. 22,and this shape allowed for the largest number of openings within theavailable area without compromising the structural integrity of thebladder. The available bladder area varies from sleeve to sleeve becauseof seam line placement and other features. The more openings, at thesame area per an opening, the greater area of the sleeve or body wrapthat is available for evaporation. The circle and larger waterdrop-shapeprovide for larger low pressure, than the medium water-drop shape of thepresent. As stated above, low pressure areas as susceptible to thepooling of blood. Table II shows the medium waterdrop-shape as thepreferred shape for the present invention. Other shapes are possible forcompression devices of different shapes and sizes. The opening shape,size and distribution defining the % Open Area are proportional to thebladder size. As stated in the present invention, the Applicantsdetermined about 6-10% Open Area per a Sleeve is preferred formaintaining clinical efficacy, while improving evaporation or coolingfor patient comfort.

The water-drop shape has one of the highest number openings for thedevice as shown in FIGS. 1 and 20. Also, the area per an openingdemonstrated good structural integrity upon wrapping as well as a shapethat allowed an evenly distributed pattern at the sleeve. This providesfor an optimal number of points of evaporation at a low % Open Area of aSleeve, but not too low of % Open Area such that evaporation will notoccur at a rate that improves patient comfort, thus, compliance. Themore openings the less distance wicked moisture will need to travel toreach the atmosphere from beneath the layers of non-woven material.

TABLE II Opening Shape Characteristics Open Area per a # of Opening OpenArea of a Opening Shape Opening at a Sleeve Sleeve 0529 Oval 0.81 236.7% 0529 Small Waterdrop 0.27 27 2.6% 0529 Medium 0.61 27 5.9%Waterdrop 0529 Large Waterdrop 1.08 20 7.7% 9529 SCD Express 0 0 0.0%0592 Circle 0.81 23 6.7%

The opening size correlated with the wicking rate and distancedetermines the evaporation of the wicked moisture.

Referring to FIG. 22, the blood flow augmentation of the mediumwaterdrop is substantially similar to the knee-length 9529 sleeve at 6%Open Area of a Sleeve. This means the clinical efficacy is maintainedwhile substantially improving comfort.

The measured blood flow augmentation is the amount of additional bloodmoved with treatment, sequential compression, as compared to notreatment. No treatment would be the blood flow of the patient at rest.Blood flow augmentation, in its measure, includes blood velocity andblood vessel diameter of a patient. Blood flow augmentation is a moreaccurate measure because it removes the affect of differing blood vesselsize between the patients. Another measure is peak velocityaugmentation. This is a measure of the highest blood flow velocityreached during a treatment cycle. The faster the velocity the more shearimparted to the blood to help prevent the formation of blood clots.

FIG. 22 shows the compression sleeve having a 6% open area and mediumwaterdrop-shaped openings each having an area of about 0.6 in² is mostsimilar to the current clinical efficacy of Kendall's 9529 model. Thesleeve having the medium waterdrop-shaped openings produced a blood flowaugmentation substantially at the 9529 SCD Express level whileincreasing evaporation of moisture more than 10% after one hour of usecompared to the current 9529 model sleeve. The peak velocity of thesleeve having the medium waterdrop-shaped openings and the 9529 devicewere within percentage points of each other, while the circle was theclosest. Though the sleeve having the large waterdrop-shaped openingsproduced the greatest blood flow augmentation, the mediumwaterdrop-shaped openings are preferred because the large open areas ofthe large waterdrop-shaped openings will likely cause blood pooling. Theresults of Kamm, and the findings of Nicolaides, Olson and Bestsuggested the more sleeve area providing compression the less likelythere is the possibly of blood to pool. Blood pooling is caused by alocalized area of low pressure created by openings or such featuresbetween areas of higher pressure.

As derived from the evaporation and hemodynamic testing, eachwaterdrop-shaped opening has an area between about 0.50 in² (3.23 cm²)and about 0.90 in² (5.81 cm²), and preferably about 0.61 in² (3.94 cm²).In one example, the openings 32 comprise between about 2% and about 20%of the total surface area of the respective inflatable bladder, and morepreferably between about 4% and about 15% of the total surface area ofthe respective inflatable bladder 24 a, 24 b, 24 c. Each opening 32 maycomprise between about 0.5% and about 1.2% of the total surface area ofthe respective bladder 24 a, 24 b, 24 c. The total percent surfaceoccupied by the openings is calculated by summing the areas of theopenings and dividing the sum by the total surface area of theuninflated bladder, where the total surface area of the uninflatedbladder includes the areas of the openings. The percent surface areaoccupied by each opening is the area of that one opening divided by thetotal surface area of the uninflated bladder, where the total surfacearea of the uninflated bladder includes the areas of the openings.

It is understood that the percentage of openings 32 may depend on thetype of compression sleeve. In an embodiment for a thigh-lengthcompression sleeve, such as the illustrated sleeve, the openings morepreferably comprise between about 4% and about 6% of the total surfacearea of the respective bladder. For example, in the illustratedembodiment, the openings 32 in the distal bladder 24 c comprise about4.36% of the total surface area of the respective inflatable bladder;the openings in the intermediate bladder 24 b comprise about 5.00%; andthe openings in the proximal bladder 24 c comprise about 5.96%. Eachopening 32 may comprise between about 0.5% and about 1.0% of the totalsurface area of the respective inflatable bladder. For example, in theillustrated embodiment, each opening 32 in the distal bladder 24 ccomprises about 0.87% of the total surface area of the respectiveinflatable bladder; each opening in the intermediate bladder 24 bcomprises about 0.72%; and each opening in the proximal bladder 24 ccomprises about 0.60%. In the illustrated embodiment, the total surfaceareas of the distal, intermediate and proximal bladders are 70.01 in²(451.68 cm²), 81.05 in² (522.90 cm²) and 102.42 in² (660.77 cm²),respectively. For example, the sleeve can have at the distal bladder 24c 5 openings; at the intermediate bladder 24 b 7 openings; and at theproximal bladder 24 a 10 openings. Moreover, all of the openings havethe same area of 0.61 in² (3.94 cm²). An opening's area may vary fromopening to opening.

In an embodiment for a knee-length sleeve, the openings more preferablycomprise between about 7% and about 10% of the total surface area of therespective inflatable bladder. In one example, openings in the distalbladder of a knee-length sleeve may comprise about 9.52% of the totalsurface area of the respective inflatable bladder; the openings in theintermediate bladder may comprise about 8.60%; and the openings in theproximal bladder may comprise about 7.77%. Each opening may comprisebetween about 0.5% and about 1.5% of the total surface area of therespective inflatable bladder. For example, each opening in the distalbladder may comprise about 1.20% of the total surface area of therespective inflatable bladder; each opening in the intermediate bladdermay comprise about 0.96%; and each opening in the proximal bladder maycomprise about 0.77%. In the illustrated embodiment, the total surfaceareas of the distal, intermediate and proximal bladders are 51.25 in²(330.64 cm²), 63.84 in (411.87 cm²) and 78.48 in² (506.32 cm²),respectively. For example, the sleeve can have at the distal bladder 8openings; at the intermediate bladder 9 openings; and at the proximalbladder 10 openings. All of the openings have the same area of 0.61 in²(3.94 cm²).

It is contemplated that the openings 32 may comprise a greater or lesserpercent of the total surface area of the inflatable bladder than givenabove. However, there is a limit to the percent opening in an inflatablesection. Experimentally total opening area above 10% is found to beuncomfortable to the patient, this relationship of opening size, thenumber of openings and their location is bounded by an upper and lowerpercent opening. In preferred embodiments of the present invention, thesleeve extends around the full circumference of the leg (or limb).However, the use of openings registered with wicking material can beincluded in other sleeves such as Huntleigh®, Hill-Rom® and Aircast®that have bladders that do not extend around the full circumference ofthe limb.

Opening location is important for comfort, use and blood flow. Recentinternal studies at the Applicants demonstrated that blood flow for thecurrent SCD Express models did not vary significantly when rotated aboutthe wearer's leg. This further supports a symmetrical distribution ofopenings around and along the patient's limb for maintaining blood flowaugmentation as was found in the testing shown in FIG. 22.

With respect to each bladder 24 a, 24 b, 24 c, the openings 32 arearranged in a distal row 36 and a proximal row 38 (FIG. 4). Both rows36, 38 extend across the respective bladder 24 a, 24 b, 24 c along thewidth W of the sleeve 10. As depicted in the drawings, the openings 32in each proximal row 38 are inverted medium waterdrop-shaped openings inthat the openings taper distally, while the openings in each distal row36 are right-side-up in that the openings taper proximally. The openings32 in each distal row 36 are offset along the width W of the sleeve fromthe openings in the respective proximal row 38. Offsetting the openings32 distributes the openings evenly across the surface area of thebladders 24 a, 24 b, 24 c, thereby increasing the breathability of thebladders and the overall breathability of the sleeve 10 withoutcompromising the structural integrity of the bladders or their abilityto apply compressive force (i.e., prophylaxis treatment) to the leg orbody part. Moreover, offsetting the openings in the respective distaland proximal rows 36, 38, also makes the bladders 34 a, 34 b, 34 c morestretchable in the widthwise direction of the sleeve 10. The aboveconfiguration allowed for one of the highest number of openings as foundin Table II. In another embodiment described below the addition ofperipheral openings 39 improved the effective or useable % Open area ofa Sleeve as explained below.

Other ways of allowing fluid wicked by the inner layer 12 to evaporate,besides the openings 32 through the bladders are within the scope of theinvention. For example, referring to FIG. 14, another embodiment of thesleeve is generally indicated at 10a. The sleeve is similar to otherembodiments in the present invention, and therefore corresponding partshave corresponding reference numerals. The difference between thissleeve 10a and the previous sleeve 10 is that in addition to the bladderopenings 32, peripheral openings 39 are formed through portions of theintermediate layers 14, 16 which do not define the bladders 24 a, 24 b,24 c (i.e., outside the peripheries of the bladder seam lines 22 a, 22b, 22 c). More specifically, the peripheral openings 39 are generallyformed through portions of the intermediate layers 14, 16 correspondingto side flaps 41 a, 41 b, or 41c of the sleeve 10. The peripheralopenings 39 are generally waterdrop-shaped but are larger than thebladder openings 32. Side flap 41 a has three peripheral openings 39,side flap 41 b has two openings and side flap 41 c has 1 opening. Likethe bladder openings 32, the peripheral openings 39 allow moisturewicked by the inner layer 12 to evaporate to the atmosphere. Theperipheral openings 39 most commonly overlap or entirely overlie thesleeve 10 when the sleeve is wrapped circumferentially around thewearer's leg and secured to itself. In that situation, the portions ofthe inner layer 12 in registration with the peripheral openings 39 arenot in direct contact with the wearer's leg. Moisture wicked by portionof the inner layer 12 in contact with the wearer's leg will move to theportions of the inner layer 12 in registration with the peripheralopenings 39 because the openings allow evaporation of the wickedmoisture (i.e., drying). Accordingly, the peripheral openings 39 providemore area for moisture to be evaporated from the inner layer 12, whichreduces the number and size of openings in the bladder area.

Referring to FIG. 15, in yet another example, the size and shape of theintermediate layers 14, 16 are such that the peripheries of the layersdo not completely cover or overlie the inner layer 12, whereby the innerlayer 12 is exposed to the atmosphere. In the illustrated embodiment,the flaps 41 a, 41 b, 41 c project laterally outward from lateral edgesof the intermediate layers 14, 16. Through this construction, largeareas of the inner layer 12 forming the flaps 41 a, 41 b, 41 c are notcovered by the intermediate layers 14, 16 and wicked fluid is allowed toevaporate through these areas. This embodiment functions in a similarmanner as the embodiment illustrated in FIG. 14, in that it allows moremoisture wicked by the inner layer 12 to be evaporated to theatmosphere. Other ways of allowing moisture wicked by the inner layer 12to evaporate into the atmosphere are within the scope of the invention.The peripheral openings 39 allow for fewer openings at the inflatablesection thereby improving blood flow to its theoretical maximum whilemaintaining the cooling affect for the patient.

With the addition of the peripheral openings 39 in the intermediatelayers 14, 16 (FIG. 14) and/or the portions of the inner layer 12 notoverlaid by the intermediate layers (FIG. 15), “a total open percentage”of the inner layer may be calculated, correlating to the total surfacearea of the inner layer not overlaid or covered by the intermediatelayers 14, 16. The total open percentage of the inner layer 12 iscalculated by summing the surface areas of all portions of the innerlayer that are not overlaid or covered by the intermediate layers 14, 16and dividing this sum by the surface area of the inner layer. Thesurface area of the inner layer 14 is determined by the peripherydimensions of the inner layer, irrespective of any holes or openings inthe layer. It is noted that the “total open percentage” of the innerlayer 12 of the previous embodiment illustrated in FIGS. 1-7 is equal tothe total surface area occupied by the bladder openings 32 of all thebladders 24 a, 24 b, 24 c divided by the total surface area of thebladders because the remainder of the intermediate layers 14, 16completely overlies or covers the inner layer. However, in the presentembodiments (FIGS. 14 and 15), the total open percentage of the innerlayer 12 is calculated by summing the surface areas occupied by theopenings 32 in the bladders 24 a, 24 b, 24 c (correlating to the totalsurface area of the inner layers in registration with the openings andtherefore “open”) together with surface areas of any other portions ofthe inner layer that is not overlain or covered by the intermediatelayers. In FIG. 14, the total open percentage of the inner layer 14 isequal to the sum of the areas of bladder openings 32 and the areas ofthe peripheral openings 39 divided by the surface area of the innerlayer.

In FIG. 15, the total open percentage of the inner layer 14 is equal tothe sum of the areas of bladder openings 32 and the surface areas of theother portions of the inner layer not covered by the intermediate layers14, 16 divided by the surface area of the inner layer. In one example,the total open percentage of the inner layer 12 may be greater thanabout 10%, more specifically, between about 10% and about 20%, withoutpatient discomfort when the openings are located at the sleeve itself.In another example, the total open percentage of the inner layer may begreater than 20%. Patient discomfort can result when the sleeve folds onitself or just does not stay snug or secure around a patient's limb.Therefore flaps are needed to hold the wrap onto the patient's bodypart. Prior art flaps would cover openings at the sleeve. By placingopenings at the flaps as shown as peripheral openings 39, the openings39 are positioned to overlay the openings 32 and the total openpercentage of the wicking material is maintained. Also, changing theopening 32 distribution not to coincide with the flaps is within thescope of this invention. Prior art devices such as U.S. Pat. No.6,592,534 to Rutt show flaps 20 that wrap over the body of the foot cuffwith no openings therethrough. Even Roth (U.S. Pat. No. 7,044,924) whichhas openings at the flaps for handles does not describe aligning theflap openings with the openings at seams of its sleeve. At FIG. 2A ofRoth, the handles 222 are off the sleeve and over the loop material atthe sleeve outer layer.

Referring to FIGS. 18 and 19, yet another embodiment of a compressionsleeve is generally indicated at 100. The flaps described provide anadjustable means to secure the wrap around the patient's limb. The flapsdescribed are typically found in the prior art, such as U.S. Pat. No.6,592,534 to Rutt, to be made of uniform, impermeable sheet with hook orloop material corresponding to loop or hook material at the outer cover.The difference is the flaps of the illustrated embodiment have anopening or cut out section from the flaps 102 a, 102 b, 102 c, whichgenerally corresponds to the opening at the outer cover or bladder areaof the sleeve. Thus, the open flap allows wicked moisture to evaporateto the atmosphere, as it is in registration with wicking material at thepatent's skin. This will reduce the number of openings otherwise need tomeet the evaporation rates needed to provide a cooler sleeve during use.

This embodiment is similar to the sleeve 10 illustrated in FIGS. 1-7,and therefore, like components are indicated by corresponding referencenumerals. The difference between the present sleeve 100 and the sleeve10 is that the present sleeve has bifurcated or split proximal andintermediate flaps 102 a, 102 b, each being indicated generally in FIGS.18 and 19. The amount of split or bifurcated distance “D” depends on thelocation and distribution of the openings 32, so the opening distance“D” overlies the maximum number of openings 32. Each of the proximal andintermediate flaps forms a pair of fingers 104 a, 104 b and 106 a, 106b, respectively, on which a fastening component 108, such as a hookcomponent, is secured. A peripheral opening 110 is formed through theintermediate layers 14, 16 at a distal, non-bifurcated flap 102 c forpurposes described above with respect to the embodiment illustrated inFIG. 14. The bifurcated flaps 102 a, 102 b make the sleeve 100 moreadjustable when securing it circumferentially around a patient's leg toallow for different leg proportions among patients and to provide morecomfort for the patient. It is understood that the flaps may be dividedinto more than two fingers and that different ones or all of the flapsmay be bifurcated.

Referring to FIGS. 16 and 17, in another embodiment of the sleeve,generally indicated at 10 c, the inner layer 12, the intermediate layers14, 16 and the outer cover 18 are secured together along a single seamline 43, which runs along the peripheries of the outer cover and thelayers. In this embodiment, it has been found that the seam line 43allows fluid wicked by the inner layer 12 to travel through theintermediate layers 14, 16 to the outer cover 18 and evaporate into theatmosphere. The outer cover 18, the intermediate layers 14, 16 and theinner layer 12 are secured to one another in a single welding step, suchas by a radiofrequency welder, after the layers have been stacked on oneanother. During this step, the intermediate layers 14, 16 are heated andsoftened along the seam line 43. The softening of the intermediatelayers 14, 16 is one way the fibers 43 a (FIG. 17) of the inner layer 12extend entirely through the seam line to the exterior of the compressionsleeve 10. The fibers 43 a are distributed uniformly throughout innerlayer 12. Thus, the inner layer 12 is able to wick fluid through theseam line 43 for evaporating into the atmosphere. The wicking layer 12can be placed between layers 14, 16 at a spot weld. A seam line may bepositioned along or around the compression device not just at theperipheral of a bladder.

Referring to FIGS. 1 and 2, the outer cover 18 of the compression sleeve10 is constructed of a single sheet of material. The outer cover 18 isbreathable and has a multiplicity of openings 40 or perforations so thatit has a mesh construction to provide even more breathability. Asuitable material for the outer cover 18 may be a polyester mesh. Therate of evaporation from the openings is improved by treating the fibersof the mesh material with a hydrophilic material. The mesh material willabsorb the wicked fluid more readily. Wicking fibers of this type areindicated generally at 21 in FIG. 7. These hydrophilic fibers lower thesurface tension of the mesh material to allow bodily fluids to moreeasily absorb into the fibers and spread therethrough for a moreefficient evaporation of the wicked fluid. Absorbing fluid more readilywill allow the fluid to move to the open areas more quickly forevaporation. The capillary effect is made more efficient as the absorbedfluid at the openings is moved more quickly through the mesh outer cover18.

Referring to FIGS. 1, 5 and 6, the outer cover 18 is secured to thesecond intermediate layer 16 along seam line 42, which runs onlyadjacent to the outer periphery of the second intermediate layer so thatthe bladders 24 a, 24 b, 24 c are free from attachment to the cover. Thesecond intermediate layer 16 may be secured to the inner layer 12 by RFwelding or adhesive or in other suitable ways.

Referring to FIGS. 1 and 7, the entirety of an outer surface of theouter cover 18 also acts as a fastening component of a fastening systemfor securing the sleeve 10 to the limb of the wearer. In a particularembodiment, the outer cover 18 of mesh (FIG. 7), for example, has anouter surface comprising loops 44 (FIG. 7), that acts as a loopcomponent of a hook-and-loop fastening system. A mesh construction, asshown in FIG. 7, has interconnected or weaved fibers 21 of materialforming the outer cover 18. The loops 44 may be formed as part of thematerial of the outer cover 18 or otherwise disposed on the surface ofthe outer cover. A suitable material with such construction is apolyester mesh loop 2103 sold by Quanzhou Fulian Warp KnittingIndustrial Co., Ltd. of Quanzhou City, China. Hook components 46 (FIG.3) are attached to an inner surface of the inner layer 12 at theproximal, intermediate and distal flaps 41 a, 41 b, 41 c, respectively.The loops 44 of the outer cover 18 allow the hook components 46 (FIG. 3)to be secured anywhere along the outer surface of the outer cover whenthe sleeve 10 is wrapped circumferentially around the limb of thewearer. This allows for sleeve 10 to be of a substantiallyone-size-fits-all configuration with respect to the circumferences ofdifferent wearers' limbs. Moreover, the outer cover 18 having the loops44 allows the practitioner to quickly and confidently secure the sleeve10 to the wearer's limb without needing to align the fasteningcomponents.

It is contemplated that the outer cover 18 may be capable of wickingfluid in addition to being breathable. For example, the outer cover 18may be constructed of the same material as the inner layer 12 (e.g.,Cool dry). In this way, the moisture wicked by the inner layer 12 may bewicked by the outer cover 18 through the openings 32 in the bladders 24a, 24 b, 24 c. The moisture will then spread out evenly across the outercover 18 and is able to evaporate more readily than if the outer coverwas not formed of a wicking material because a greater surface area ofthe outer cover, as opposed to the inner layer 12, is exposed to air.Alternatively, the cover can have a wicking material laced in or on topof outer layer.

Referring to FIG. 13, yet another embodiment of the sleeve is generallyindicated at 80. The difference between this sleeve and the firstembodiment 10 is that the inner layer 12 and the outer cover 18 aresecured to each other at seam lines 82 through the openings 32 in thebladders 24 a, 24 b, and 24 c to maintain the inner layer and outercover in direct contact. In this embodiment, both the inner layer 12 andthe outer cover 18 are constructed of suitable wicking material, such asCoolDry or CoolMax®. By being in constant contact, the outer cover 18continuously wicks moisture from the inner layer 12 through the openings32 in the bladders 24 a, 24 b, 24 c. As explained above, in this way alarger surface area having wicked moisture is exposed to air and thewicked moisture can evaporate more quickly.

The compression sleeve 10 as a whole is more comfortable to wear becauseof the synergistic relationship of the layers 12, 14, 16, 18. Forexample, the inner layer 12 is capable of wicking moisture from the limband allowing the moisture to evaporate out of the sleeve 10. As statedabove, wicking involves transporting moisture away from the limb andmoving moisture from locations where it is abundant and transporting itto areas where it is less abundant. Material decreases its wicking ratewhen the moisture is equally distributed in the wicking material and thewicking material is saturated. However, the breathability of the sleeve10 allows for the wicked moisture to evaporate. The waterdrop-shapedopenings 32 in the bladders 24 a, 24 b, 24 c and the breathable outercover 18 allow moisture in the inner layer 12 that is adjacent to theopenings to evaporate therethrough. Accordingly, as the moistureevaporates, it is transported to the drier portions of the inner layer12, and the inner layer is able to wick more moisture. Testing describedbelow supports the findings of breathable outer cover improves thecooling affect to the patient. If one places the openings 32 at thecorner points of a generally square pattern, then the middle of thesquare is theoretically the farthest distance trapped moisture must bewicked in terms of distance to an opening. The closer the openings aretogether the more rapidly the wicked moisture is evaporated because thedistance to an opening is shortened. The further apart the openings, thegreater the distance the wicked moisture must travel and the lesscomfort the device provides to the patient, in terms of cooling. Thetesting described below helped determine the optimum spacing and size toprovide cooling without compromising blood flow as shown in FIG. 22.

Summarized in Table III are the evaporation test results of anembodiment constructed according to the principles of the presentinvention having the waterdrop-shaped opening as compared withcompetitor sleeves A and C.

TABLE III Evaporation Rates by Sleeve Present Prior Art Invention SCDWaterdrop- Express shape 9529 Sleeve A Sleeve C Entire Sleeve Area 280264 210 198 (in²) Available Bladder 173 178  55  58 Area (in²) % ofBladder Area  61.8%  67.4%  26.2%  29.3% % of Open Area  5.9%  0.0% 0.0%  0.0% through Bladder of Entire Sleeve Average Evaporation 0.03268  0.00598  0.0424  0.03488 Rate (g/min) Average Evaporation 0.00012  0.00002  0.00020  0.00018 Rate per in² of Entire Sleeve(g/min/in²) Average Evaporation  0.02019  0.00403  0.01110  0.01022 RateVs. Bladder Coverage (g/min)

For purposes of this application, the following test (referred to hereinas the “static evaporation test”) is used to determine the rate ofevaporation of moisture wicked by the wicking layer through sleeve(e.g., through the openings, at the seam lines and/or the other portionsof the bladder layers not overlying the wicking layer). The results aresummarized in Table III. A polycarbonate plate is placed on a digitalscale. The polycarbonate plate has a peripheral shape matching theperipheral shape of the sleeve to be tested, so that the sleeve may besuperposed on the plate. The digital scale has a 2000 gram capacity witha 0.01 gram resolution. After the plate is placed on the scale, thescale is zeroed. Next, a mixture of room temperature tap water and foodcoloring (e.g., red food coloring) is sprayed onto the polycarbonateplate using a spray bottle. About 18 to 20 grams of the mixture issprayed generally uniformly across the surface area of the plate. Thesleeve to be tested is then placed on the plate so that the sleeve isgenerally flat on the plate and generally superposed thereon. The massreading on the scale is recorded, along with the room temperature andthe relative humidity. Every 30 minutes for at least 5 hours, the massreading on the scale, the room temperature and the relative humidity arerecorded. After completion of the test, with the sleeve still on theplate, a photograph of the underside of plate is taken to capture thedistribution of any remaining fluid on the plate and the sleeve.Finally, using the recorded data, the evaporation rate and percentage offluid evaporated by mass (e.g., mg/minute) for each sleeve iscalculated.

Using the above-described static evaporation test, a sleeve of the typeillustrated in FIG. 20 was tested. The same testing procedure can beapplied to the other embodiments, such as the full length sleeve ofFIG. 1. It was shown that moisture wicked by the inner layer of thesleeve was able to evaporate through each opening of the sleeve at arate of between about 0.5 mg/minute and about 2.0 mg/minute and morespecifically, between about 1.1 mg/minute and about 1.5 mg/minute. Theoverall rate of evaporation through all of the openings was betweenabout 20 mg/minute and about 50 mg/minute and more specifically, betweenabout 30 mg/minute and about 40 mg/minute. As explained above, ingeneral the static evaporation test showed that increasing thepercentage of the openings with respect to individual bladders increasedthe evaporation rate of the sleeve. The increase in evaporation rate didnot increase proportionally above 30% total open percentage of the innerlayer 12. It is also contemplated that using an inner layer that iscapable of wicking fluid at a faster rate may also increase theevaporation rate of the sleeve. Other ways of increasing the evaporationrate of the sleeve are within the scope of the present invention.

The overall breathability of the sleeve 10 also aids in keeping thesleeve comfortable for the wearer. Because the inner layer 12, thebladders 24 a, 24 b, 24 c and the outer cover 18 are breathable, thelimb has access to air and heat is allowed to dissipate out of sleeve.The waterdrop-shaped openings 32, through their number and locationalong and around the sleeve, allow a significant amount of air to reachthe limb and a significant amount of heat and moisture therein to beremoved from the sleeve. This has the effect of keeping the limb cooland comfortable for the wearer.

The calculation of evaporation results, as found in Table III above isdetermined by the following equations:% of liquid evaporated, LEi=((Wsn−Wso)−(Wsn-1−Wso))/(Wsn−Wso),

-   -   Where LEi is the incremental % of liquid evaporated at a given        data point;    -   Where Wsn is the weight of the sample at the desired data point;    -   Where Wsn-1 is the weight of the sample at the previous data        point;    -   Where Wso is the original dry weight.        % of liquid evaporated,        LEc=[((Wsn−Wso)−(Wsn-1−Wso))/(Wsn−Wso)]+ΣnLEi,    -   Where ERc is the cumulative % of liquid evaporated;    -   Where Wsn is the weight of the sample at the desired data point;    -   Where Wsn-1 is the weight of the sample at the previous data        point;    -   Where Wso is the original dry weight;    -   Where ΣnLEi is the summation of the previous incremental % of        liquid evaporated.        Evaporation Rate, ER=(Wsn-1−Ws)/Δt,    -   Where Wsn-1 is the weight of the sample at the previous data        point;    -   Where Ws is the current weight of the sample;    -   Where Δt is the change in time between Wsn-1 and Ws.

To improve patient mobility, the sleeve was designed to have an elasticinner layer 12 and outer cover 18. An elastic sleeve improves comfortwhich increases patient compliance. Refer to FIGS. 1-7 for thediscussion on elasticity below. An elastic device will conform to apatient's limb to ensure continuous wicking. A compliant orsubstantially conforming fit will help ensure the contact of the bladderagainst a patient's skin during use. The bladder applies the pressure tomove the blood. The elastic outer layer helps reduce number of straps tohold the sleeve in place because the elastic outer layer 18 returns itsoriginal shape exerting a slight force against the patient's limb. Thisforce helps hold the sleeve in place and also allows the practitionernot to over tighten a strap. Some prior art devices use an elasticstocking, such as the T.E.D.® stocking, beneath the compression sleeve.The compression sleeve of at least some embodiments avoids the two stepprocess of first placing the compression stocking on the patient, thenplacing the sleeve over the stocking. Also sleeves of preferredembodiments of the present invention simplify the job of the nursesbecause there is no need to order a stocking and sleeve.

The Applicant devised an elasticity test for determining the amount ofstretch around the limb and along the limb. A patient needs to be mobileduring treatment. Prior art sleeves can be awkward, stiff and heavy sothe user would remove the device, if they needed to move about. The needis to improve elasticity without distorting the openings 32 too muchsuch as becoming elongated or causing an opening to overlie, whichreduces its size for evaporation.

For example, the inner layer 12 is preferably elastically stretchablealong the width W of the sleeve 10 so that the inner layer is able toconform circumferentially to the shape of the wearer's limb. Conformingcircumferentially allows the inner layer 12 to remain in close, intimateand continuous contact with the wearer's limb to ensure that the innerlayer is continuously wicking moisture from the limb. The inner layer 12may also be stretchable the length L. Preferably, the inner layer 12 iselastically stretchable along both the width W and the length L of thesleeve and is more elastically stretchable along the length of thesleeve 10 than along the width. Summarizing the preferred approach,using the test described below, the inner layer 12 may have an averageelasticity in the widthwise direction of the sleeve of between about 13lbs/in (23 N/cm) and about 14 lbs/in (25 N/cm), and in one embodimenthas an elasticity of about 13.3 lbs/in (23.3 N/cm). The inner layer 12may have an average elasticity in the lengthwise direction of the sleeveof between about 0.5 lbs/in (0.9 N/cm) and about 0.7 lbs/in (1.2 N/cm),and in one embodiment has an elasticity of about 0.63 lbs/in (1.10N/cm). The small openings 20 in the inner layer 12 also allow for theinner layer stretch more.

The outer cover 18 is also elastically stretchable along the length L ofthe sleeve 10 or stretchable along both lengthwise and widthwise(circumferentially). Preferably, the outer cover 18 is more elasticlongitudinally than widthwise. Although elastically stretchable, theouter cover 18 acts to restrain the amount of expansion of the bladders24 a, 24 b, 24 c. The outer cover 18 helps to conform the bladder to thelimb for helping to evenly apply pressure for moving blood. For example,using the elasticity test described below, the outer cover 18 may havean average elasticity in the widthwise direction of between about 13lbs/in (23 N/cm) and about 15 lbs/in (26 N/cm), and in one embodimenthas an elasticity of about 13.6 lbs/in (23.8 N/cm). The outer cover 18may have an average elasticity in the longitudinally direction ofbetween about 19 lbs/in (33 N/cm) and about 22 lbs/in (39 N/cm), and inone embodiment an elasticity of about 19.8 lbs/in (34.7 N/cm).

The compression sleeve 10 as a whole is stretchable longitudinally byway of the longitudinally stretchable inner layer 12, intermediatelayers 14, 16 and outer cover 18. Further, the sleeve 10 is slightlystretchable widthwise by way of the abilities of the inner layer 12,intermediate layers 14, 16 and the cover 18 to stretch widthwise. Thewaterdrop-shaped openings 32 and the fact that the openings are offsetwidthwise also aid in the widthwise stretching.

It is common for patients that have undergone surgery to incur swellingof the limbs. The widthwise stretching of the sleeve 10 is morecomfortable for patients that experience swelling because the sleevewill stretch, i.e., increase in size circumferentially, as the limbswells. Moreover, elasticity of the sleeve 10 allows the wearer to havemore mobility of his or her limb and gives the practitioner a greaterdegree of freedom when wrapping the sleeve around a wearer's leg. Forexample, using the elasticity test described below, the thigh-lengthsleeve 10, comprising the inner layer 12, the intermediate layers 14, 16and the outer cover 18 as described above, may have an averageelasticity in the widthwise direction of between about 22 lbs/in (39N/cm) and about 27 lbs/in (47 N/cm), and in one embodiment an elasticityof about 24.3 lbs/in (42.6 N/cm). The compression sleeve 10 may have anaverage elasticity in the lengthwise direction of between about 17lbs/in (30 N/cm) and about 22 lbs/in (39 N/cm), and in one embodiment anelasticity of about 19.4 lbs/in (34.0 N/cm).

In another example, using the elasticity test described below, aknee-length sleeve, comprising an inner layer, intermediate layers andouter cover of the same material as the thigh-length sleeve describedabove, may have an average elasticity in the widthwise direction ofbetween about 22 lbs/in (39 N/cm) and about 27 lbs/in (47 N/cm), and anaverage elasticity in the lengthwise direction of between about 33lbs/in (58 N/cm) and about 40 lbs/in (70 N/cm).

The following test (herein referred to as the “elasticity test”) is usedto measure the elasticity of the layers 12, 14, 16 and 18 and the sleeve10, both widthwise and lengthwise. First, structure clamps are securedto the structure (e.g., one of the layers 12, 14, 16, and 18 or thesleeve 10) to be tested. When testing the lengthwise elasticity, thestructure clamps are secured to top and bottom edges of the structure.When testing the widthwise elasticity, the structure clamps are securedto opposite side edges of the structure. The sleeve sample with thestructure clamps secured thereto is placed in a universal tensiletesting machine (such as a universal testing machine manufactured byInstron® of Grove City, Pa.) by securing the structure clamps toopposing machine clamps of the machine. The machine should include amicroprocessor having a tensile force measurement program used tocontrol the machine and record measurements of force and displacement.Once the structure is secured in the machine, the opposing machineclamps are moved apart to a position that eliminates or minimizes theslack in the structure. This position is the initial position for allsubsequent tests. The tensile force measurement program is thenexecuted. The displacement of the sleeve sample as the machine clampsare moved apart should be uniform linear elongation and should notdamage the structure. This displacement is set and maintained for eachtest repetition. The test is repeated 7 times for each layer 12, 14, 16and 18 and the sleeve 10. Elasticity is calculated as force (lbs)divided by the displacement (in). An average elasticity of the 8 testsis calculated by summing the elasticity calculations for the 8 tests anddividing the sum by 8.

The sleeve in some embodiments is made more comfortable for the wearerby the fact that the inner layer 12 and the outer cover 18 are securedto the respective intermediate layers 14, 16 only adjacent to the outerperipheries of the inner layer and cover whereby the bladders 24 a, 24b, 24 c are not secure directly to the inner layer and cover. Thisconstruction allows for the bladders 24 a, 24 b, and 24 c to moveindependently of the inner layer 12, and vice versa. Co-assigned U.S.Patent Application Ser. No. 11/299,568 disclosing an embodiment directedto reducing chafing of a person's skin during use is incorporated hereinby reference.

Thus, when the sleeve 10 is wrapped circumferentially around thewearer's limb, the inner layer 12 substantially conforms to the contouror shape of the limb and will remain substantially stationary againstthe wearer's limb as the bladders 24 a, 24 b, 24 c inflate and deflateand/or shift positions. The movement of the bladders 24 a, 24 b, 24 cboth as they inflate and deflate and shift positions relative to thelimb may cause chaffing and other discomfort for the patient if thesurface of the bladders continuously rubbed against the limb. However,by being secured only at the outer peripheries of the intermediatelayers 14, 16, the inner layer 12 creates a buffer between the bladders24 a, 24 b, 24 c and the limb that prevents chaffing and other frictionagainst the skin of the limb. The bladders 24 a, 24 b, 24 c may movewithout causing corresponding movement of the inner layer 12 against theskin.

Referring now to FIGS. 8 and 9, another embodiment of the sleeve isgenerally indicated at 50. This embodiment 50 is similar to the firstembodiment 10, and therefore, corresponding parts will be indicated bycorresponding reference numbers. The difference between the presentembodiment 50 and the first embodiment 10 discussed above is that eachof the intermediate layers 14, 16 comprises three separate sheets 52 a,54 a, 56 a and 52 b, 54 b, 56 b, respectively. Correspondingintermediate sheets 52 a, 52 b and 54 a, 54 b and 56 a, 56 b, aresecured together to form the three separate bladders 24 a, 24 b, 24 c(FIG. 9). The remainder of the sleeve 50 is constructed similar to thefirst embodiment, including the intermediate sheets 52 a, 54 a, 56 a and52 b, 54 b, 56 b being secured only adjacent to the respectiveperipheries of the outer cover 18 and the inner layer 12 so that thecentral portions of the bladders 24 a, 24 b, 24 c are free fromsecurement to the inner layer and outer cover. It is also contemplatedthat adjacent bladders 24 a, 24 b, 24 c may be connected to each otherby elastically stretchable material other than the inner layer 12.

In addition to the advantages given above with respect to the firstembodiment 10 of the compression sleeve, the present embodiment 50 alsoallows for better fit to a given individual's leg because the ability ofthe sleeve to stretch longitudinally is dependent only on thestretchabilities of the inner layer 12 and cover 18. In one embodiment,the inner layer 12 and the outer cover 18 are more stretchable than theintermediate layers 14, 16, and in particular, more stretchablelongitudinally than the inner layer and the outer cover. Thus, thesleeve 50 may stretch between the proximal and intermediate bladders 24a, 24 b without shifting the locations of the bladders on the leg (i.e.,the bladders remain in place). In one example, at least one of the innerlayer 12 and outer cover 18 is not resilient so that the sleeve 50retains its stretched form after stretching. In another example, atleast one of the inner layer 12 and outer cover 18 is resilient so thatthe sleeve 50 returns to its original form after a stretching force isreleased. The ability of the sleeve 50 to elastically stretch allows forthe practitioner to readily adjust the positions of the bladders withrespect to the wearer's limb. It is also contemplated that anotherstretchable component or material, other than the inner layer and theouter cover, may connect adjacent bladders.

Referring to FIGS. 10-12, yet another embodiment of a compression sleeveis generally indicated at 60. Sleeve 60 is similar to the firstembodiment, and therefore, like parts are indicated by correspondingreference numerals. The difference between this sleeve 60 and the firstembodiment 10 is that inflatable bladders, generally indicated at S1,S2, S3 (FIG. 11), are generally S-shaped and do not include openingsformed therethrough.

Each S-shaped bladder S1, S2, S3 is formed by securing the twointermediate layers 14, 16 together along an S-shape seam line 64. TheS-shaped bladders S1, S2, S3 each include spaced apart proximal,intermediate and distal (or “first, second, and third”) sections 66, 68,70, respectively, along the length L of the sleeve 60. The generalshapes of the bladders S1, S2, S3 are indicated by a centerline in FIG.10. Holes 72 are formed through the intermediate layers 14, 16 betweenthe proximal and intermediate portions 66, 68, respectively, of thebladders S1, S2, S3 and the intermediate portion and distal portion 70of the bladders. Referring to FIG. 12, instead of numerous openings 72,continuous slits 74 may extend along the width of the sleeve 60substantially the entirety of the length of the space between disposedbetween the proximal and intermediate portions 66, 68 and intermediateportion and distal portion 70 of each bladder S1, S2, S3. Theopenings/slits 72, 74 may be other shapes and sizes. Additionalopening(s) may also be formed through the intermediate layers 14, 16between the individual bladders S1, S2, S3 to make the sleeve 60 morebreathable. For example, in the illustrated embodiment, an opening 75 islocated between the bladders S2 and S3. Moreover, it is understood thatthe S-shaped bladders may include the openings (e.g., like openings 32)through the bladders S1, S2, S3 as shown in the first embodiment withoutdeparting from the scope of the invention. Alternatively, as with thesleeve 50 embodied in FIGS. 8 and 9, the bladders S1, S2, S3 may beformed separately from separate intermediate sheets and may be spacedapart longitudinally along the sleeve 60. The remainder of the sleeve 60may be constructed in the same manner as described above with respect tothe first and second embodiments.

The present sleeve 60 allows for large openings 72, 74, 75 to be formedthrough the intermediate layers 14, 16, thereby making the sleeve morebreathable and allowing for more moisture to dissipate through thesleeve, without forming openings through the bladders S1, S2, S3.Openings 72, 74 in the sleeve 60 are spaced at smaller intervals alongthe length L of the sleeve without forming holes through the bladdersS1, S2, S3 than if the bladders were not S-shaped.

In another embodiment shown in FIG. 14, the distal and intermediatebladders 24 c, 24 b, respectively, share a portion of their seam lines22 c, 22 b, respectively. This portion of seam lines 22 c, 22 b isgenerally wavy so that portions of the intermediate bladder 24 b aredistal of adjacent portions of the distal bladder 24 c, andcorrespondingly, portions of the distal bladder are proximal of adjacentportions of the intermediate bladder.

As is known in the art, the bladders 24 a, 24 b, 24 c are pressurized todifferent pressures. For example, the distal bladder 24 c is pressurizedto a higher pressure than the intermediate bladder 24 b. The wavyportion of the seam lines 22 c, 22 b creates a transition sectiondefined by the wavy portion having a pressure that is between the highpressure of the distal bladder 24 c and the lower pressure of theintermediate bladder 24 b. The wavy transition section, in effect,avoids a region of essentially zero pressure and helps prevent poolingof blood between the adjacent bladders 24 b, 24 c. Industry studiesperformed by Nicolaides, Olson and Best all describe the importance ofpreventing the pooling of blood that can lead to venous stasis—acondition having a high occurrence of leading to a pulmonary embolism.

Referring now to FIG. 20, another embodiment of a compression sleeve isgenerally indicated at 200. This sleeve is a knee-length sleeve. Thesleeve 200 is similar to the sleeve illustrated in FIGS. 1-7, and likeparts are indicated by corresponding reference numerals plus 200. Thesleeve 200 includes a wicking, breathable inner layer 212, intermediatelayers 214, 216 defining three bladders 224 a, 224 b, 224 c, and abreathable outer cover 218. Openings 232 are formed in each of thebladders 224 a, 224 b, 224 c to allow moisture (e.g., moisture) wickedby the inner layer 212 to evaporate through the intermediate layers 214,216 and the outer cover 218. The difference between the present sleeve200 and the sleeve 10 illustrated in FIGS. 1 -7 is that the presentsleeve is sized and shaped to be received around the lower portion ofthe leg below the knee. Thus, the sleeve 200 does not have bridgemembers or a knee opening. Instead, the three bladders 224 a, 224 b, 224c are conjoined. It is understood that the sleeve 200 may have otherconfigurations and/or characteristics, such as those described above inreference to other embodiments, without departing from the scope of thepresent invention.

When introducing elements of the present invention or the preferredembodiments(s) thereof, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

In view of the above, it will be seen that the several objects of theinvention are achieved and other advantageous results attained.

As various changes could be made in the above constructions, products,and methods without departing from the scope of the invention, it isintended that all matter contained in the above description and shown inthe accompanying drawings shall be interpreted as illustrative and notin a limiting sense.

What is claimed is:
 1. A device for applying compression treatment to apart of a wearer's body, the device comprising at least one inflatablebladder formed from opposed layers of bladder material, the bladderbeing constructed so that when worn on the part of the wearer's bodyinflation of the bladder applies a compressive force to the part of thewearer's body to move blood within the wearer's body part, the at leastone bladder having a generally S shape compression region with first,second and third spaced apart sections in fluid communication, at leastone opening being formed between the first and second sections, the atleast one opening extending through both layers of bladder material andhaving an area of greater than about 0.50 in² (3.23 cm²) to providecommunication from an area under the layers of bladder material to alocation above the layers of bladder material.
 2. A device as set forthin claim 1 wherein the pair of opposing layers of bladder material aresecured together along a seamline to define the S-shaped compressionregion.
 3. A device as set forth in claim 2 comprising plural openingsextending through both layers of bladder material defining the at leastone inflatable bladder and located between the first and second sectionsof the S-shaped compression region.
 4. A device as set forth in claim 3wherein the layers defining the at least one bladder have pluralopenings extending through both layers between the second and thirdsections, the openings between the second and third sections beingoutside of the S-shaped compression region.
 5. A device as set forth inclaim 2 comprising a single opening in the layers of bladder materialdefining the at least one bladder located between the first and secondsections of the compression region.
 6. A device as set forth in claim 5wherein the single opening located between the first and second sectionsextends along substantially an entire length of the first and secondsections.
 7. A device as set forth in claim 6 further comprising asingle opening in the layers of bladder material defining the at leastone bladder between the second and third sections, the single openingbetween the second and third sections extending through both layers ofbladder material and along substantially an entire length of the secondand third sections.
 8. A device as set forth in claim 2 wherein theS-shaped compression region constitutes a first S-shaped compressionregion, the device further comprising a second S-shaped compressionregion with at least first and second spaced apart sections, and atleast one opening being formed between the first and second sections ofthe second S-shaped compression region, the at least one opening betweenthe first and second sections of the second S-shaped compression regionextending through both layers of bladder material.
 9. A device as setforth in claim 8 further comprising an opening between the first andsecond S-shaped compression regions.
 10. A device as set forth in claim8 further comprising a third S-shaped compression region.
 11. A deviceas set forth in claim 1 further comprising a layer of wicking materialattached to the device and located on a side of the at least one bladderthat engages the wearer's body part in use, the wicking layer beingexposed to atmosphere through the at least one opening.